There are a number of emergency measures which may help to contain or ameliorate an infectious
disease outbreak. The Public Health Service Act and the Stafford Act contain authorities that
allow the Secretary of Health and Human Services and the President, respectively, to take certain
actions during emergencies or disasters. While the primary authority for quarantine and isolation
in the United States resides at the state level, the federal government has jurisdiction over
interstate and border quarantine. Border entry and border closing issues may arise in the context
of measures designed to keep individuals who have, or may have, influenza A(H1N1) from
crossing U.S. borders. Aliens with the H1N1 virus can be denied entry, but American citizens
cannot be excluded from the United States solely because of a communicable disease, although
they may be quarantined or isolated at the border for health reasons. Airlines have considerable
discretion to implement travel restrictions relating to the safety and/or security of flights and other
passengers and crew. In addition, the federal government has broad legal authority to regulate and
control the navigable airspace of the United States in dealing with incidents involving
communicable diseases. States have authority to initiate other emergency measures such as
mandatory vaccination orders and certain nonpharmaceutical interventions such as school
closures, which may lessen the spread of an infectious disease. The International Health
Regulations adopted by the World Health Organization in 2005 provide a framework for
international cooperation against infectious disease threats.


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The then-Acting HHS Secretary issued a nationwide public health emergency declaration in
response to recent human infections from the influenza A(H1N1) virus on April 26, 2009. Making such a determination enables the Secretary to take three types of actions that can be especially
useful for dealing with an emerging influenza outbreak. First, such a determination authorizes the
Secretary to draw from a special emergency fund.4 Second, it enables the Secretary to implement
an authority in the Federal Food, Drug, and Cosmetic Act—the so-called Emergency Use
Authorization—allowing for the use of unapproved medical treatments and tests, under specified
conditions, if needed during an incident.5 Third, if there is a concurrent declaration pursuant to
the Stafford Act6 or the National Emergencies Act, 7 the Secretary is authorized to waive or
modify a number of administrative requirements, principally involving reimbursement through
the Medicare and Medicaid programs, in order to facilitate the provision of health care items and
services by providers in any geographic area subject to the concurrent declarations.


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Specifically, the Secretary may take some or all of the
following actions:
• Waive conditions of participation, certification requirements, program
participation, and pre-approval requirements under Medicare, Medicaid, or the
Children’s Health Insurance Program;9
• Permit health care providers to provide care under Medicare, Medicaid, or the
Children’s Health Insurance Program, even if they are not licensed by the state
with jurisdiction over the emergency area;10
• Waive sanctions under the Emergency Medical Treatment and Active Labor Act
for certain transfers or redirections of patients away from hospital emergency
rooms;
Waive sanctions for violations of the Stark law, which prohibits certain selfreferrals
by physicians;12
• Extend deadlines and other timetables for required activities;13
• Waive limitations on payments under Medicare Advantage for care and services
provided by out-of-network providers;14 or
• Waive sanctions and penalties for violations of the HIPAA Privacy Rule such as
the use of protected health information for hospital directories, the disclosure of
protected health information to patients’ families and friends, the distribution of
health care providers’ and insurers’ privacy policies to patients, and individuals’
rights to request restrictions, privacy restrictions, or confidential
communications.15
These waivers and modifications may be retroactively applied by the Secretary to the beginning
of the period during which the concurrent declarations were in effect, and will generally remain in
effect until either of the underlying emergency declarations ends or sixty days have elapsed since
the date on which notice of the waivers or modifications was published


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With respect to the current outbreak, the Public Health Emergency Fund is available (but is
currently unfunded)17 and Emergency Use Authorizations have been granted by FDA.18 However,
the Secretary’s waiver and modification authority has not been activated because there is no
concurrent presidential declaration under either the Stafford Act or the National Emergencies Act.9comment: report published in May 2009)


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A presidential declaration under the Stafford Act triggers federal emergency authorities that are
independent of the Secretary’s public health emergency authorities. Declarations under the
Stafford Act fall into two categories: emergency declarations and major disaster declarations. As
of this point in time, there have been no Stafford Act declarations pertaining to the current
influenza A(H1N1) virus outbreak.(MAY 2009) A presidential emergency declaration under the Stafford Act
authorizes the President to direct federal agencies to support state and local emergency assistance
activities; coordinate disaster relief provided by federal and non-federal organizations; provide
technical and advisory assistance to state and local governments; provide emergency assistance
through federal agencies; remove debris through grants to state and local governments; provide assistance to individuals and households for temporary housing and uninsured personal needs;
and assist state and local governments in the distribution of medicine, food, and consumables.19
The total amount of assistance available is limited in an emergency declaration to $5 million,
“unless the President determines that there is a continuing need; Congress must be notified if the
$5 million ceiling is breached.


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Emergency declarations under the Stafford Act in the event of an outbreak of infectious disease
are not unprecedented. In 2000, the detection of West Nile virus in New York and New Jersey
was used as the basis of an emergency declaration under the Stafford Act.21 However, there may
be uncertainty regarding whether a flu pandemic, or any outbreak of infectious disease, would be
eligible for major disaster assistance under the Stafford Act


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A major disaster declaration authorizes the President to offer all the assistance authorized under
an emergency declaration, and further authorizes funds for the repair and restoration of federal
facilities, unemployment assistance, emergency grants to assist low-income migrant and seasonal
farm workers, food coupons and distribution, relocation assistance, crisis counseling assistance
and training, community disaster loans, emergency communications, and emergency public
transportation.23 Additionally, the total amount of assistance provided in a major disaster
declaration is not subject to a ceiling in the same way as under an emergency declaration.


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Although there are differences between the types and amounts of assistance that are authorized by
an emergency or major disaster declaration, either declaration would activate the Secretary’s
waiver or modification authority,25 if concurrent with a public health emergency declaration.